The primary objective of the study is to assess the proportion of neonates with hyperbilirubinaemia necessitating treatment that is detected using universal TcB screening compared to using only visual inspection, while decreasing the number of heel…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of the study is the added value of universal TcB screening
compared to only visual inspection to detect neonatal hyperbilirubinaemia
requiring treatment, while decreasing the need for heel pricks to quantify
total bilirubin in blood.
As such, the study has two primary endpoints, assessed at each time point for
each newborn in the study: 1. LBB above the treatment threshold; 2. Need for a
heelprick (to determine LBB).
Secondary outcome
• Diagnostic properties of Bilistick®.
• Difference in time-to-test result between LBB and Bilistick® (in minutes).
• Difference in blood volume between LBB and Bilistick® (in µl).
• Diagnostic properties of Picterus® app vs. TcB and LBB.
• Added value of Picterus® app compared to only visual inspection in picking up
neonates with hyperbilirubinaemia requiring treatment, while reducing the need
for heel pricks to quantify bilirubin in blood.
• Potential cost-effectiveness of implementation of the novel methods in daily
practice.
• Proportion of neonates receiving phototherapy.
• Proportion of neonates having a LBB level above the phototherapy threshold.
• Proportion of neonates having a LBB level above the exchange transfusion
threshold.
• Proportion of neonates who actually received an exchange transfusion.
Background summary
Neonatal jaundice occurs in up to 85% of term newborn infants. It is caused by
elevated circulating bilirubin levels that peak in the first week of life.
However, when bilirubin levels are very high and left untreated, bilirubin may
pass the blood-brain barrier and cause permanent brain damage (also called
kernicterus spectrum disorder; KSD). Timely recognition and treatment of severe
neonatal hyperbilirubinaemia is thus essential. In current practice, visual
inspection is used as a first-line screening tool to assess jaundice. However,
visual inspection is known to be unreliable and reliance on visual inspection
to detect neonatal jaundice can cause significant diagnostic and therapeutic
delay. Accordingly, bilirubin levels rise to dangerous levels sufficiently
severe to cause imminent KSD in a significant number of neonates each year.
Novel screening and diagnostic methods for early detection of potentially
severe neonatal hyperbilirubinaemia are urgently needed in order to prevent
KSD.
Study objective
The primary objective of the study is to assess the proportion of neonates with
hyperbilirubinaemia necessitating treatment that is detected using universal
TcB screening compared to using only visual inspection, while decreasing the
number of heel pricks to quantify total bilirubin in blood (per neonate).
Study design
Prospective observational study.
Study burden and risks
In this study, we will investigate three novel approaches to recognise and
diagnose neonatal hyperbilirubinaemia:
1. TcB screening
TcB measurement is safe and has been shown to be effective in reducing the
incidence of severe hyperbilirubinaemia in other settings. TcB quantification
is a non-invasive and painless procedure which involves holding the device to
the neonate*s skin for a few seconds.
2. Picterus mHealth app
Picterus® is a mobile application that uses a photograph of the sternum with a
colour calibration card to estimate total bilirubin levels. This application is
installed on a smartphone provided by the study team.
3. Bilistick®
Bilistick® is a POC instrument to quantify bilirubin in one drop of whole blood
drawn from a heel prick. Bilistick® will only be used if LBB quantification is
needed, based on visual inspection and/or TcB screening. Accordingly,
participating neonates will not need an extra heel prick for Bilistick®
assessment.
As neonates are the only group suffering from neonatal hyperbilirubinaemia,
these three novel approaches can only be investigated in neonates/in the
neonatal phase.
In conclusion, we consider the risks low, whereas the novel approaches have
potential to offer major benefits to neonates.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
• Born at a gestational age of at least 35 weeks.
• Cared for at home between day 2 and 8 of life.
• Having a first midwife visit at home prior to day 6.
• Written informed consent according to the national guidelines of both parents
or legal representatives. Given the low risks of participating in the study,
referred consent of the second parent is allowed as well.
Exclusion criteria
• The neonate previously received phototherapy (as reliability of TcB
measurement is reduced in neonates who have received phototherapy).
• The neonate has parents who do not have sufficient understanding of the Dutch
language to be able to comprehend the patient information sheet.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL74483.078.20 |
| OMON | NL-OMON23353 |